Posted by The medical devices market for ENT in India is valued at 213.59 Million USD in 2024. This figure is set to grow at a CAGR of 8.51% until 2032. Thus, opportunities for businesses, both domestic and abroad, to import or produce ENT medical devices are plenty. However, to be successful in this endeavour, you must have a CDSCO ENT medical devices license.
The road to get this approval can be bumpy due to many rules and requirements set up by the issuing authority. By correctly following them, your path for getting the license becomes easier. Read on to learn all about it below.
What are the ENT Medical Devices?
ENT Medical devices are surgical and non-surgical instruments to treat, diagnose, or improve conditions related to the ear, nose, and throat. Some common examples include audiometer, antitampering device, hearing aids and implants, and surgical devices. If they need to be imported, produced, or marketed, they must be of high quality and as per the norms set by CDSCO.
CDSCO’s Role in Providing Medical Devices Import & Manufacturing License For ENT
CDSCO plays a key role in granting manufacturing and ENT medical device import licenses in India. It sets the classification of devices in different risk categories and gives guidelines on investigating licensing requirements for these devices. CDSCO’s approved ENT devices are those that abide by the Medical Devices Rules, 2017. This is an act that governs the import, production, distribution and sale of Medical Devices in India.
Without the approval of DCGI, it is unlawfully for ENT devices to enter into the Indian market and be used by clinicians and researchers. Additionally, CDSCO also takes care of post-market surveillance of medical devices. This includes ensuring that manufacturers & Importer report adverse events, stop producing unsafe devices, Field Safety Corrective Actions (FSCA), and submit data from adverse event reports and user complaints. It also oversees whether they are taking preventive measures.
Classes of ENT Medical Devices in India
ENT medical devices are categorized into different classes. The classification is according to the risk associated with each device and follows a four-tier model:
- Class A: Low-risk devices, like tongue depressors, otoscopes, ENT chairs, and ear bowl
- Class B: Low to moderate risk devices, like audiometer and impedance audiometer
- Class C: Moderate to high-risk devices, like Cochlear implant assessment system and larynx prosthesis.
- Class D: High-risk devices
CDSCO Classification of ENT Medical Devices
This table lists the different risk classes to which all ENT medical devices belong.
|
S. No |
Medical Device Name |
Risk Class |
| 1 | Adenotome | A |
| 2 | Adenotome blade | B |
| 3 | Audiometer testing system | A |
| 4 | Audiometer | B |
| 5 | Evoked response auditory stimulator | B |
| 6 | Behind-the-ear air- conduction hearing aid | B |
| 7 | Behind-the-ear air- conduction tinnitus masker | B |
| 8 | Behind-the-ear bone- conduction tinnitus masker | C |
| 9 | Cochlear implant assessment system | C |
| 10 | Ear bowl | A |
| 11 | Ear canal impression tray | A |
| 12 | Ear canal light | A |
| 13 | Ear excavator | A |
| 14 | Ear prosthesis | C |
| 15 | Ear wick | A |
| 16 | Electroglottograph | B |
| 17 | Endaural curette | A |
| 18 | ENT chair, electric | A |
| 19 | ENT chair, mechanical | A |
| 20 | ENT shaver system | B |
| 21 | ENT surgical microscope | A |
| 22 | ENT transilluminator | A |
| 23 | Evoked-potential audiometer | B |
| 24 | Flexible fibreoptic nasopharyngo laryngoscope | B |
| 25 | Flexible fibreoptic nasopharyngoscope | B |
| 26 | Flexible fibreoptic rhinoscope | B |
| 27 | Flexible fibreoptic sinoscope | B |
| 28 | Flexible video antroscope | B |
| 29 | Impedance audiometer | B |
| 30 | Nasal septum straightening forceps | A |
| 31 | Otoscope, endoscopic | A |
| 32 | Tonsil knife | A |
| 33 | Tracheal bistoury | A |
| 34 | Middle ear mold | C |
| 35 | Fully-implantable middle ear implant system | C |
| 36 | Larynx prosthesis | C |
| 37 | Epistaxis balloon | B |
| 38 | Eustachian tube balloon dilation system | B |
| 39 | Argon laser for otology, rhinology, and laryngology | C |
| 40 | Ear, nose, and throat microsurgical carbon dioxide laser | C |
| 41 | Esophagoscope (flexible or rigid) | B |
| 42 | Mediastinoscope and accessories | B |
| 43 | Laryngostroboscope | B |
| 44 | Bone particle collector | A |
| 45 | Suction antichoke device | C |
| 46 | Tongs antichoke device | C |
| 47 | Powered nasal irrigator | B |
| 48 | External nasal splint | A |
| 49 | Antistammering device | B |
| 50 | External upper esophageal sphincter compression device | C |
| 51 | Wireless air-conduction hearing aid | B |
| 52 | Hearing aid calibrator and analysis system | B |
| 53 | Tympanic membrane contact hearing aid | B |
| 54 | Master hearing aid | B |
| 55 | Active implantable bone conduction hearing system | C |
| 56 | Battery-powered artificial larynx | B |
| 57 | Nasal dilator | A |
| 58 | Transcutaneous air conduction hearing aid system | C |
| 59 | Acoustic chamber for audiometric testing | A |
| 60 | Gustometer | B |
| 61 | ENT cupped forceps | A |
| 62 | Tongue depressor | A |
| 63 | Tonsillectome | A |
| 64 | ENT Nasal snare | A |
| 65 | Otoscope, direct | A |
| 66 | Soft-tissue surgical forceps, alligator | A |
| 67 | Ear, nose, and throat electric or pneumatic surgical drill | B |
Types of Licenses for Manufacturing & Importing ENT Devices
Based on your needs, you must apply for different licenses. The CDSCO ENT medical devices import license is Form MD-15. It is applicable to import all classes of ENT medical devices. The application to get this license is submitted in Form MD-14.
To manufacture Class A and B ENT devices, you will need Form MD- 5/ Form MD-6 licenses, and for Class C and D ENT devices, you require Form MD-9/ Form MD-10 license issued by the respective Licensing Authority.
Process to Get CDSCO ENT Medical Devices License for Import and Manufacturing:
To get an ENT medical devices import license in India or approval for manufacturing, you must follow the process laid out by CDSCO. Here are the steps that every individual or entity should follow. As always, you can seek our guidance or end-to-end support throughout the process or at any stage.
1. Device Classification
Determine the device class (A, B, C, or D) as per the Medical Device Rules (MDR), 2017. As said before, this classification is based on the level of risk associated with your device.
2. Know the Licensing Authority
The licensing authority differs based on whether you intend to manufacture or import and class of ENT medical device. The State Licensing Authority is the issuer of manufacturing license of ENT devices falling in Class A and B, while CDSCO is the central authority to get an ENT medical devices import license and manufacturing license of Class C & D.
3. Process for Manufacturers to Get the License
Manufacturers of ENT medical devices should follow this sequence to gain approval.
- Ensure your ENT device is on the CDSCO’s notified list. For this, check the official notification on CDSCO’s website.
- Register and create an account on the Medical Device SUGAM Portal for your application submission and tracking.
- Prepare the required documents. These include:
- Device Master File (DMF)
- Plant Master File (PMF)
- Risk Management Report
- ISO 13485 certificate
- Site plans/layouts
- Details of qualified staff
4. Application Submission
Submit the relevant Form (MD-3/MD-4 for A/B, MD-7/MD-8 for C/D). Do this via the Medical Device SUGAM portal with the prescribed fees.
5. Inspection & Review
Licensing Authority reviews the application and will audit & conduct thorough facility inspections in case of manufacturing license.
6. License Issuance
Upon approval, you will receive a Medical device license. The validity is for 5 years. You must renew it after this period.
7. Process for Importers
If you aim to get import license for ENT Medical Device, use the following process.
- Know your class and fees: You require Form MD-15 to import your ENT Medical devices. Fees depend on the device risk class and are paid per site & number of the device.
- Then, appoint an Indian Authorized Agent (IAA). Foreign manufacturers must appoint an authorized agent in India. The agent should have a valid wholesale or manufacturing license.
- The next step is to register on the Medical Device SUGAM Portal. All Authorized agents must register on this Portal.
- After registering, it is time to compile documentation, which includes:
- Device Master File (DMF)
- Plant Master File (PMF)
- Free Sale Certificate
- ISO 13485 Certificate
- CE Certificate
- Declaration of Conformity
- Risk analysis documents
- Power of Attorney
8. Submit Import License Application
This step involves submitting the MD-14 (application) form and uploading all documents. Next, pay the applicable import license fees:
- Class A: USD 1,000 per site and USD 50 per device
- Class B: USD 2,000 per site and USD 1000 per device
- Class C & D: USD 3,000 per site and USD 1500 per device.
9. Review of Application
CDSCO reviews documents and may request clarification or additional documents.
10. License Issuance (Form MD-15)
Upon satisfactory review of your documents, CDSCO will issue the import license. It is valid for five years.
How Dueran Consultant Helps You?
We have a team of highly qualified and experienced regulatory professionals who have been helping individuals and businesses get licenses for manufacture, import, sale, clinical investigation and more. If you face issues with the accuracy and completeness of your documents or compliance or want to address queries raised by the issuing authority, connect with Dueran Consultant team to get proactive support. With custom regulatory solutions and strategies, we smoothen your registration process so your devices gain the approval to enter and flourish in the Indian market.
Frequently Asked Questions (FAQ’s)
1. What are the medical devices for ENT?
Medical devices for ENT are specialized instruments used in the diagnosis, examination, surgery, and treatment of ear, nose, and throat conditions. Some common examples are otoscopes, hearing aids, and tongue depressors.
2. What is ENT Equipment?
ENT equipment are devices used to treat conditions like hearing disorders, thyroid disorders, and sleep disorders. They are made from high-quality and strong materials, like steel and comply with standards like ISO 13485.
3. What are the innovations in ENT?
In India, advanced equipment for treating and diagnosing ENT conditions is developing. These include surgical implants like cochlear implants, electronic devices, image-guided systems for real-time anatomical information, and an Information Management System with Device and Voice Control to control devices without hands through voice commands.
